MedTrace Logo

Pain Assessment and Quality of Life in Back Pain Patients: Role of Milnacipran

NCT01221740 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-01-12

No results posted yet for this study

Summary

1. To show that patients with greater pain sensitivity will show greater improvement in their symptoms (self-reported pain intensity, mood, sleep, and quality of life) than those with lower pain sensitivity, based on QST, after taking milnacipran.
2. To compare outcome differences (pain intensity, mood, activity interference, sleep, and side effects) with those patients who are either taking or not taking opioids for their pain 10 weeks after being prescribed milnacipran.
3. To show that patients who are older, male, with more medical comorbidities, greater disability, and longer pain duration will report less improvement (pain, mood, sleep, health-related quality of life) and treatment satisfaction while taking milnacipran compared with others without such characteristics.

Conditions

Interventions

DRUG

Savella

The patients will be titrated to the maintenance dose of 50 mg BID over a 7-day period, and will be on the medication for 10 weeks. 12.5 mg QD on day 1 12.5 mg BID on days 2 and 3 25 mg BID on days 4, 5, 6, and 7 50 mg BID beginning day 8

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01221740 on ClinicalTrials.gov